What is Plenadren - Hydrocortisone?
Plenadren is a medicine that contains the active substance hydrocortisone. It is available in modified-release capsules (5 mg and 20 mg).
What is Plenadren - Hydrocortisone used for?
Plenadren is used to treat adrenal insufficiency in adults. Adrenal insufficiency (including primary insufficiency or Addison's disease) is a condition in which the adrenal glands that (located just above the kidneys) do not produce enough of a steroid hormone called cortisol (also known as the stress as it is released in response to stress.) Symptoms include weight loss, muscle weakness, asthenia, low blood pressure, and sometimes darkening of the skin. Adrenal insufficiency may need lifelong treatment to replace the cortisol deficiency.
Because the number of patients with adrenal insufficiency is low, the disease is considered 'rare' and Plenadren was designated an 'orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
The medicine can only be obtained with a prescription.
How is Plenadren used?
Plenadren tablets are taken once a day early in the morning, swallowed whole with a glass of water at least 30 minutes before a meal. The daily dosage is usually between 20 and 30 mg, but this must be adjusted individually in based on the patient's reaction. In situations of excessive physical or mental stress or illness, patients may need additional doses of hydrocortisone. In these cases, Plenadren tablets can be administered two or three times a day or it is possible to use immediate-release tablets or injections, either alone or in combination with Plenadren.
How does Plenadren - Hydrocortisone work?
The active substance in Plenadren, hydrocortisone, is the pharmaceutical form of cortisol, the primary steroid hormone secreted by the adrenal gland. Hydrocortisone replaces the naturally missing cortisol in patients with adrenal insufficiency. It has been used in drugs for several decades.
As it is available in modified release tablet form, Plenadren releases hydrocortisone for a longer period thus allowing it to be taken once a day. It should be taken early in the morning as the amount of cortisol in the blood normally increases early in the morning in people. healthy.
How has Plenadren - Hydrocortisone been studied?
The applicant presented data on experimental models from the scientific literature.
The effects of Plenadren were studied in one main study involving 64 patients with adrenal insufficiency. Plenadren, given once a day, was compared with conventional hydrocortisone treatment which is given three times a day. The study looked at patients' blood cortisol levels over a 24-hour period after three months of treatment.
What benefit has Plenadren - Hydrocortisone shown during the studies?
In patients taking Plenadren the cortisol levels achieved were considered satisfactory for patients with adrenal insufficiency. The overall amount of cortisol absorbed into the blood was 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatments.
What is the risk associated with Plenadren - Hydrocortisone?
The most common side effect with Plenadren (seen in more than 1 in 10 patients) is asthenia. For the full list of side effects reported with Plenadren, see the package leaflet.
Plenadren must not be used in people who may be hypersensitive (allergic) to hydrocortisone or any other ingredient in the medicine.
Why has Plenadren - Hydrocortisone been approved?
The CHMP noted that Plenadren achieved satisfactory cortisol levels during the treatment of patients with adrenal insufficiency. The committee also noted the practicality of dosing for taking Plenadren once daily. Although once daily dosing runs the risk of cortisol levels dropping too low in the afternoon, this problem can be addressed by adding additional doses of hydrocortisone as needed.
The CHMP concluded that Plenadren's benefits outweigh its risks and recommended that it be given a Marketing Authorization.
More information about Plenadren - Hydrocortisone
On 03 November 2011, the European Commission issued a "Marketing Authorization" for Plenadren, valid throughout the European Union.
For more information about Plenadren therapy, read the package leaflet (also included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08/2011.
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